Information-driven pharmaceutical adherence packaging

ABSTRACT

A prepackaged medication system and method is provided to increase patient compliance with prescribed medications. The system comprises providing patients with customized packaging for all of their prescription medications organized by administration timepoint. Since all medications for an individual patient may be packaged in a customized form, a listing of all medications and prescribing physician information may be provided to patients and maintained for reference and use by physicians in evaluating treatment regimens. The method comprises obtaining prescription data from a patient, entering the obtained data into a database, extracting and organizing the patient&#39;s prescription data, generating a customized packaging layout for all of the patient&#39;s prescription medications organized by day and administration timepoint, filling each medication container within the package with the appropriate medication(s) and shipping either directly to the patient or to the patient&#39;s pharmacy.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to an information-driven prepackaged medication system, and associated methods designed to increase compliance with pharmaceutical prescriptions.

2. Description of the Related Art

Failure by patients to comply or adhere to prescribed pharmaceutical medication schedules is a major health care and economic concern. Noncompliance with prescription medication schedules results either in under-treatment or over-treatment and suboptimal health outcomes. Failure to adhere to prescription medication administration schedules is directly linked, by one estimate, to more than 125,000 deaths annually in the United States, while hundreds of thousands more patients endure prolonged recovery periods or never fully recover.

The health impact of noncompliance also gives rise to large economic costs. For example, studies find that noncompliance costs than $100 billion in lost productivity and unnecessary medical costs, more than $200 billion per year in unnecessary costs to health care payers, and more than $30 billion per year is lost by pharmaceutical companies.

A large proportion of patient noncompliance results from confusion with complicated medication regimens. Patients often are prescribed several medications, any of which may be required to be administered in different dosages/amounts at several points over the course of a day, causing confusion in the most alert of patients. This confusion may be compounded by factors arising within an aging patient population, including inter alia cognitive impairment and related conditions.

In some cases, noncompliance results from error stemming from medication repackaging processes conducted by the patient or the patient's care giver. Outpatient medications often go through several packaging and repackaging processes before they are consumed by the patient. Each packaging and repackaging process provides opportunity for mistakes, reducing adherence to treatment regimens.

For example, a typical sequence for packaging of outpatient medications begins with a first packaging step by the medication manufacturer in bulk for distribution to a retail pharmacy. The bulk medication is then repackaged by a pharmacist into a pill bottle or other container based on the supply of medication required for a given prescription, e.g., 30 pills for a 30 day prescription. Patients who take multiple medications each day often repackage them from the pill bottles supplied by a pharmacy into a daily medication organizer, i.e., compartments for each day of the week, Sunday through Saturday.

The initial two steps of this typical process, manufacturer packaging and pharmacist repackaging, ensure to the extent possible that the correct medication is provided to the patient in the correct quantity. However, neither of these processes address improving patient adherence and compliance, particularly when more than one medication is prescribed and/or at least one medication requires multiple doses each day. In addition, the last step, repackaging by the patient, is most dangerous because of the potential for introducing significant error. Some patients, particularly the elderly, become confused by the complexity of multiple medication regimens and/or lack sufficient manual dexterity, visual acuity and/or mental alertness to organize and repackage medications correctly and safely.

The concept of a packaging container and/or system for storing and dispensing individual doses of medication is well known in the art. Current packaging systems comprise, e.g., blister cards or packs and cassettes.

Blister packs are the most widely used system for long-term care as well as and maintenance and over-the-counter (OTC) medications and are produced by many manufacturers. Each blister card is a plastic sheet molded with pill-holding blisters, encased on a fold-over card with holes cut on each side. One side of the card accommodates the blisters while the other side is backed with foil. The pill in the blister is released when pushed through the foil backing. Primary disadvantages of this packaging system are that presently only one medication per blister pack is provided; it can be difficult for some patients to remove the medication contained therein, and such systems are not customizable to the individual patient.

Cassettes are reusable plastic containers that may contain one or more pills per cavity and are filled manually by the pharmacist. Cassettes are reused, so there is a risk of cross-contamination from pills previously housed in the cavities. Such cassettes are not designed to handle all medications for an individual patient, nor is there a method or system known that would accommodate such a customized approach.

Some of these known packaging systems or containers include instructions for when to take the medication. Others have indicia printed alongside the individual doses of medication to remind the patient when to take the medication.

Problems with such packaging systems are that the indicia and/or instructions are integrated with the packaging and not customizable to the patient. In addition, individual medications only are provided. So a patient may have several such packaging systems and in such a situation may be compelled to repackage, introducing error.

It is apparent that there is a need for a customizable packaging system and method that eliminates the need for patient repackaging of medications and that increases compliance with pharmaceutical prescriptions.

BRIEF SUMMARY OF THE INVENTION

A prepackaged medication system and method is provided to increase patient compliance with prescribed medications. The system comprises providing patients with customized packaging for all of their prescription medications organized by administration timepoint. Since all medications for an individual patient may be packaged in a customized form, a listing of all medications and prescribing physician information may be provided to patients and maintained for reference and use by physicians in evaluating treatment regimens. The method comprises obtaining prescription data from a patient, entering the obtained data into a database, extracting and organizing the patient's prescription data, generating a customized packaging layout for all of the patient's prescription medications organized by day and administration timepoint, filling each medication container within the package with the appropriate medication(s) and shipping either directly to the patient or to the patient's pharmacy.

An object of the present invention is to provide a customized prepackaged medication system and method that is designed to increase the patient's ability to comply with their prescription pharmaceutical treatment plans.

Another object of the present invention is to provide a prepackaged medication system and method that is customizable for each individual patient's medication regimen.

Another object of the present invention is to provide a customized prepackaged medication system and method that provides comprehensive medications for each administration timepoint over a period of time.

Yet another object of the present invention is to provide a customized prepackaged medication system and method that eliminates at least one repackaging step, thereby increasing patient adherence and compliance with treatment regimens.

Another object of the present invention is to provide a customized prepackaged medication system and method that comprises improved quality control and eliminates error.

Another object of the present invention is to provide a customized prepackaged medication system and method that comprises a logical evaluation of medications packaged together in the packaging system before dispensing into the package containers and visual inspection after dispensing.

Another object of the present invention is to provide a customized prepackaged medication system and method whereby all medications taken by a patient can be monitored, facilitating evaluation by the patient's physician.

Another object of the present invention is to provide a customized prepackaged medication system and method that generates a listing of all medications and prescribing physician information are developed and maintained for reference and use by the patient and for use by physicians in evaluating treatment regimens.

Still another object of the present invention is to provide a customized prepackaged medication system and method that provides the patient with improved medical information about the medications provided therein as well as greater reliability in identifying particular medications.

Another object of the present invention is to provide a customized prepackaged medication system and method that allows the pharmacist additional time to consult with the patient instead of spending time repackaging medications.

Another object of the present invention is to provide customized prepackaged medication system and method that comprises an automated ability to proactively detect the need for refills for all of a patient's prescription requirements and to obtain necessary prescriptions from physicians without action by the patient.

The figures and the detailed description which follow more particularly exemplify these and other embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, which are as follows.

FIG. 1A is perspective view of one embodiment of the present invention.

FIG. 1B illustrates one embodiment of a medication container for the present invention.

FIG. 2 is a top view of one embodiment of the present invention.

FIG. 3 is a perspective view of one embodiment of the present invention.

FIG. 4 provides a process flow of one embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

While the invention is amenable to various modifications and alternative forms, specifics thereof are shown by way of example in the drawings and described in detail herein. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

Referring now to FIG. 1A, one embodiment of the prepackaged medication system 10 is illustrated. A medication container support 20 is shown comprising a plurality of apertures 30. A plurality of medication containers 40 are shown supported by the medication container support 20.

FIG. 1B illustrates one embodiment of medication container 40. Each medication container 40 comprises an opening 42 that is operably associated and substantially aligned with one medication container support aperture 30. The medication container opening 42 and the support aperture 30 are each preferably sufficiently sized and shaped so as to allow for dispensing of medication contained within the medication container 40 to or by the patient.

The medication container 40 support may be comprised of cardboard, hardened plastic, a combination thereof, or any material or combination of materials that provides sufficient support for the medication containers 40. The material selected may be coated. Those skilled in the art will recognize equivalent materials.

In the present embodiment, the medication containers 40 are represented as cylindrical, having a height H and a diameter D with the opening 42 located at the upper end of the container 40. Alternatively, the medication containers 40 may be shaped differently, the opening located in a different position and still remain within the scope of the present invention as will be recognized to those skilled in the art.

Alternatively, the support and entire set of medication containers may be thermoformed in a one-piece construction. Different versions of this packaging may be made available for varying dose timepoints each day as well as varying the height of the containers to accommodate varying volumes of medications.

The medication containers 40 are preferably made of a translucent plastic material allowing visual inspection of the contents by a pharmacist or other inspector. The container 40 thickness may be comparable to that of blister packs, containers well known in the art, providing sufficient mechanical protection for the medication contained therein. The plastic may be 100% ultraviolet resistant to prevent light from adversely affecting the medications during storage, transportation or when under the patient's or caregiver's control.

Each medication container 40 may have a constant consistent diameter D, allowing for a consistent spacing when the containers 40 are all engaged with the medication container support 20. In this embodiment, accommodation of large size and/or volumes of medications for particular administration timepoints is achieved by increasing the height H of the container in incremental fashion until the size/volume of the medication at issue is accommodated.

Alternatively, an individual container's diameter D may be allowed to vary in addition to, or in lieu of, increasing or decreasing the length of the cup's depth to accommodate all sizes/volumes of medications for each timepoint.

One embodiment of the medication container 40 may have a lip, not shown in the figures, to assist in engaging the medication support container apertures 30. Such a lip would preferably extend outwardly from the opening 42.

A medication seal is provided to maintain the integrity of the medication contained within the medication container as is well known to those skilled in the art and, as such, is not shown in the figures. Such medication seal may comprise removable strips covering the aperture 30 and/or associated medication container opening 42, as well as the medication contained therein. In an alternate embodiment, individual seals may be provided to cover each aperture 30 and/or medication container opening 42 as well as the medication contained within the individual medication container 40. Another embodiment may comprise the medication seal as an unbroken sheet of material that provides protective coverage of the medication contained within each medication container 40.

The medication seal may be simply a series of perforated seals, the perforations separating days of the week from each other, or administration timepoints from each other, or a combination thereof, as is well known in the art. The seal may be comprised of plastic or foil. If plastic, the material may be translucent to allow viewing into the medication container contents.

In any of the alternate embodiments described above comprising a medication seal, seal tabs may be provided to assist the patient, or their caregiver, in removing the seal to expose the medication within as is well known in the art.

One embodiment of the medication container support is shown in a top view in FIG. 2. The apertures 30 are represented as circular in this embodiment; however any shape that allows dispensing or extraction of medication from the medication container 40 through the medication container opening 42 disposed and aligned beneath the aperture 30 may be used as will be readily apparent to those skilled in the art.

In this embodiment, the apertures 30 are arranged organizationally and logically within a medication administration matrix to provide administration information to the patient. In this embodiment, the medication administration matrix is comprised of individual columns 52 representing each day of the week, i.e., Sunday through Saturday. The medication administration matrix rows 54 represent administration timepoints for when the medication is to be taken, e.g., breakfast, lunch, dinner and bedtime, over the course of a day. Individual matrices may be identified in this construct by (Row, Column). Thus, in this embodiment, (Dinner, Monday) locates one medication administration timepoint matrice 56 within the administration matrix. Other equivalent administration matrix constructions, including inter alia rows for the days of the week and columns for administration timepoints, may present themselves to those skilled in the art and are within the scope of the present invention.

The indicia 60, in the illustrated embodiment days of the week, alternatively comprising administration timepoints within days, may be provided on the medication container support 20. The indicia 60 may be printed in one or more languages, including Braille to facilitate understanding and compliance. In the embodiment illustrated in FIG. 2, the indicia 60 on the medication container support 20 comprises days of the week. Administration timepoints such as Breakfast, Lunch, Dinner and Bed Time may also be provided as suggested by the Figure. Any combination or graphical representation of days and/or administration timepoints will be readily apparent to those skilled in the art and is well within the scope of the present invention.

Further, to assist patients and caregivers, the columns and/or rows of the medication container support 20 may themselves be color coded in some fashion, e.g., alternation of light and dark color to avoid confusion due to color blindness. Moreover, the indicia may incorporate some color coding, e.g., by time of day. Thus, as illustrated in FIG. 2, the Breakfast and Dinner administration timepoint rows are, across all days, lighter in shading than Lunch and Bed Time administration timepoints.

The medication container support 20 may comprise seven days of the week and four administration timepoints as shown in FIGS. 1A and 2. Alternatively, more or fewer days and/or timepoints may be presented to the patient, depending upon the prescription requirements. Thus the layout of the medication container support 20 may be driven based entirely upon the individual patient's prescription requirements, providing a wholly customizable solution.

By way of example, a patient may have prescription medications to be taken twice a day in the morning and at bedtime and another medication to be administered only once per day, in the morning. Thus, the medication container support and medication container layout may comprise, e.g., seven columns, each corresponding to one day of the week and just two rows, corresponding to the morning and bed time administration timepoints in the example. All medications to be taken are included within the appropriate medication container 40. The exemplary daily containers 40 corresponding with the morning timepoint will have both prescribed medications within them, while the bedtime containers only have one medication, as prescribed. Thus, the exemplary medication card support 20 preferably comprises apertures 30 and associated medication containers 40 that directly reflect, in customized fashion, the individual patient's prescription needs.

Alternatively, apertures 30 may be provided to correspond with seven columns, one for each day of the week, and four administration timepoint rows wherein only the apertures 30 required by the patient's prescription requirements have medication containers 40 associated therewith, leaving the remaining apertures 30 either open or uncut and medication containers, if present, unoccupied by medications. In this manner, and equivalents thereof, any variation with a patient's prescription schedule may be accommodated with the present invention.

Where locating the medication container support apertures 30, and associated medication containers 40, is an automated process, as is the preferential embodiment, driven by the patient's prescription requirements, the apertures 30 may be located by cutting into and through the medication container support 20 and then placing the containers 40 into the aperture 30, or otherwise fixing the container 40 in place. Alternatively, the device 10 may be formed by custom forming medication containers from a continuous card, preferably made of translucent plastic, in a unitary body construction configuration.

In an alternate embodiment, the medication container support 20 may be perforated, thus allowing detachment and removal of individual medication containers 40. The medication containers 40, thus removed, may remain sealed. In this manner, patients may transport individual containers 40, with medication, in a discrete manner. In various embodiments, detachable containers 40 may have indicia 60 printed on the surface of the container to provide the patient with administration information.

Significantly, the medication(s) provided to the patient in a single medication container 40 is driven and informed by, inter alia, integrated information comprising all medications taken by a patient under the present invention. This is the result of integrating all of preferably all of a patient's prescriptions, not just a single written prescription for a single medication, as is the current practice. Preferably, the patient-specific prescription information and/or data, as well as patient medical and identification data, are compiled in a database. The database may be accessed to generate medication container support aperture 30 layouts, with associated medication containers, that are entirely customized in accordance with an individual patient's prescription requirements.

The acquisition and integration of the patient's comprehensive prescription information further allows for comprehensive supplementary information to be supplied to the patient about the medications provided with the customized packaging. For example, pictures may be included to help identify the individual medications, a descriptive listing of each medication, including warnings and/or other label information may be included with the customized medication package. A listing of all medications included and prescribing physician information may also be included with the packaging for reference and for use by physicians to evaluate treatment regimens and track health outcomes. Preferably this information is compiled within a database.

As illustrated in FIG. 3, a childproof cover 60 may be provided to increase safety by minimizing unwanted access to the device 10 and the medication therein. Various embodiments of the childproof cover 60 may be made of a hardened plastic, preferably opaque. The cover 60 may slip over the medication container support 20 as illustrated, obscuring the medication from view. Further, the cover 60 may comprise an internal lock as is well known by those skilled in the art that removably lockingly engages the medication container support 20.

One embodiment of a method according to the present invention is illustrated in FIG. 4. The method 200 begins with obtaining data about the patient and the patient's prescriptions 210. Preferably all prescriptions written for the patient are included in this data gathering step, however, information about less than all prescriptions may be obtained. Prescription data comprises the medication, dose and administration regimen, length of prescription, refill information and prescribing physician information. Patient data comprises relevant information such as patient name, known allergies to medications and contact/shipping information and the like.

After the patient and prescription data are obtained, the data is entered into a database 220. The database 220 may be queried to extract or pull patient-specific data 230. Based upon the patient-specific data extraction in step 230, customized medication packages are assembled in step 240. This may comprise generating and/or developing a customized layout of the medication container support and assembly of the support and medication containers (if separate components) based upon the individual patient's prescription requirements as described in detail above. Further, step 240 comprises filling the containers with all appropriate medication(s) for a particular day and administration timepoint. This may be accomplished by pulling the medications from bulk stock.

Prior to filling the packages, in some embodiments a logical evaluation of the medications to be filled may be conducted. This may be completed manually, by a pharmacist, pharmacy technician or the like. Alternatively, the evaluation may be conducted automatedly by a software program, well known in the pharmaceutical arts. The evaluation may comprise a quality control check for duplication of medications, medication interactions, comparison of the medications prescribed with the patient's known allergy information and the like.

When the package is filled according to the prescription data from step 230, may then be sealed, and labeled, including indicia where appropriate. Further, customized supplementary information, discussed above in detail, regarding the medications contained therein may be provided. Because the medication containers and/or seals may be comprised of translucent plastic or other substantially clear material, visual and/or other quality control checks may be made periodically throughout the filling and packaging process.

Ultimately, the customized medication package is filled, sealed and ready to provide to the patient 250. Provision of the medication package may entail simply mailing directly to the patient. Alternatively, the customized package may be shipped to a third party, e.g., a retail pharmacy where the patient may pick up the medication(s). In this embodiment, a pharmacist may conduct a visual quality control check of the medications against the prescriptions, consult with and/or answer questions from the patient. The pharmacy may further receive payment and complete any remaining insurance claims information.

Alternative embodiments may comprise the continued and automatic monitoring of the patient-specific prescription data in the database for refill timepoints. When an impending refill timepoint is detected by the database monitoring, an automatic refill of the outstanding prescriptions may be initiated and completed as described above. In this manner, the patient is provided refills on time and without interruption.

It is understood that the system and method described herein are amenable and applicable to the broadest definition of prescription medications and patients. For instance, as used herein, medications may also include over-the-counter medications or nutritional supplements like vitamins. Likewise, patients comprise humans as well as animals and, consequently, medications comprise medications prescribed for humans as well as animals.

The present invention should not be considered limited to the particular examples described above, but rather should be understood to cover all aspects of the invention. Various modifications, equivalent processes, as well as numerous structures to which the present invention may be applicable will be readily apparent to those of skill in the art to which the present invention is directed upon review of the present specification. 

1. A prepackaged medication system provided to patients for improving ease of use and increasing compliance with prescription medications comprising: at least one medication container support having a plurality of apertures, each aperture arranged on the at least one support by administration timepoint; a plurality of medication containers supported by the at least one medication container support, each container having an opening, wherein the opening is in operable association with one medication container support aperture and each container is capable of containing all medications prescribed to be administered at the corresponding administration timepoint; and a seal removably protecting all medication contained within each medication container.
 2. The prepackaged medication system of claim 1, wherein each medication container is customizably sized to allow containment of any combination and quantity of medications prescribed to the patient for the corresponding corresponding administration timepoint.
 3. The prepackaged medication system of claim 1, wherein the apertures are arranged by day and timepoint within day.
 4. The prepackaged medication system of claim 1, wherein the arrangement of the apertures and associated medical containers is defined by the patient's prescription requirements.
 5. The prepackaged medication system of claim 1, further comprising customizable indicia on the medication container support.
 6. The prepackaged medication system of claim 1, wherein the at least one medication container comprises translucent material.
 7. The prepackaged medication system of claim 1, wherein the seal comprises translucent material.
 8. The prepackaged medication system of claim 1, wherein the seal further comprises a tab to facilitate removal.
 9. The prepackaged medication system of claim 1, further comprising the medication containers being detachable from the medication container support.
 10. The prepackaged medication system of claim 1, further comprising a childproof cover.
 11. The prepackaged medication system of claim 10, wherein the childproof cover is made of hardened plastic.
 12. The prepackaged medication system of claim 1, further comprising a listing of all medications of all medications, dosages, medication interactions and prescribing physician information.
 13. The prepackaged medication system of claim 1, further comprising a database comprising patient-specific prescription data, wherein the arrangement of apertures and size of individual medication containers are customized in accordance with the patient-specific prescription data.
 14. A prepackaged medication system, comprising: a database comprising patient-specific prescription data; at least one medication container support having a plurality of apertures, each aperture arranged on the at least one support by administration timepoint in correspondence with the patient-specific prescription data; a plurality of medication containers supported by the at least one medication container support, each container having an opening, wherein the opening of is in operable association with one medication container support aperture and each container is capable of containing all medications prescribed to be administered at the corresponding administration timepoint, and wherein the size of each medication container is customized in accordance with the patient-specific prescription data; and a seal removably protecting all medication contained within each medication container.
 15. A method for increasing patient compliance with pharmaceutical prescriptions, comprising: obtaining patient-specific prescription, medical and identification data; entering the obtained data into a database; extracting the patient-specific data from the database; a. generating customized packaging to accommodate all of the patient's prescription medications; packaging the patient's prescription medications in the customized packaging; and providing the patient with the prepackaged medications.
 16. The method of claim 15, further comprising performing at least one logical evaluation of the medication to be packaged.
 17. The method of claim 16, wherein the at least one logical evaluation is performed automatically by software.
 18. The method of claim 15, further comprising performing at least one visual quality control check of the medication after packaging and prior to providing to the patient.
 19. The method of claim 15, further comprising providing customized supplementary medication information to the patient.
 20. The method of claim 15, wherein the extracting, generating and packaging are automated processes.
 21. The method of claim 15, further comprising detecting the need for refills.
 22. The method of claim 21, further comprising providing the detected refills to the patient without action by the patient. 